Status:
TERMINATED
P3: Pacemaker Patient Profiling Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Brief Summary
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemak...
Eligibility Criteria
Inclusion
- Patient meets Class I / Class II indications for pacing
- Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System
Exclusion
- Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
- Patient whose life expectancy is less than two years
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
2013 Patients enrolled
Trial Details
Trial ID
NCT00294060
Start Date
March 1 2004
End Date
November 1 2007
Last Update
May 6 2011
Active Locations (83)
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1
Birmingham, Alabama, United States
2
Prescott, Arizona, United States
3
Little Rock, Arkansas, United States
4
Aliso Viejo, California, United States